Suturing systems and methods

ABSTRACT

A medical device including an elongate member extending from a proximal end toward a distal end, the elongate member having a lumen with a longitudinal axis, a hub portion towards the proximal end of the elongate member and configured for a user to hold and manipulate a position of the elongate member, a base portion including a first groove and a second groove separated by an opening, and two wings disposed towards a distal end of the medical device, the two wings being opposite each other across the longitudinal axis and on opposite sides of the base portion, wherein, the two wings are configured to move in relation to the longitudinal axis and wherein each wing has an elongate slot having a closed first end at a location between the base portion and a peripheral end of the wing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/936,781, filed Jul. 23, 2020, which is a continuation of U.S. patentapplication Ser. No. 15/949,642, filed Apr. 10, 2018, which is acontinuation of U.S. patent application Ser. No. 15/162,030, entitled“Needle Removal Devices, Systems, and Methods”, filed May 23, 2016,which is a divisional of U.S. patent application Ser. No. 13/610,598,entitled “Needle Removal Devices, Systems, and Methods”, filed Sep. 11,2012, now U.S. Pat. No. 9,345,474, the disclosures of which areincorporated herein by this reference.

BACKGROUND OF THE INVENTION 1. The Field of the Invention

Embodiments of the invention relate generally to devices, systems, andmethods devices for removing needles from systems or devices used toclose openings in body lumens. More particularly, the present inventionrelates to devices, systems, and methods for removing needles fromsystems or devices used for closure of arterial and venous puncturesites accessed through a tissue tract.

2. The Relevant Technology

A number of diagnostic and interventional vascular procedures are nowperformed translumenally. A catheter is introduced to the vascularsystem at a convenient access location and guided through the vascularsystem to a target location using established techniques. Suchprocedures require vascular access, which is usually established usingthe well-known Seldinger technique. Vascular access is generallyprovided through an introducer sheath, which is positioned to extendfrom outside the patient's body into the vascular lumen. When vascularaccess is no longer required, the introducer sheath is removed andbleeding at the puncture site stopped.

One common approach for achieving hemostasis (the cessation of bleeding)is to apply external force near and upstream from the puncture site,typically by manual compression. However, the use of manual compressionsuffers from a number of disadvantages. For example, the manualcompression procedure is time consuming, frequently requiring one-halfhour or more of compression before hemostasis is achieved. Additionally,such compression techniques rely on clot formation, which can be delayeduntil anticoagulants used in vascular therapy procedures (such as forheart attacks, stent deployment, non-optical PTCA results, and the like)wear off. The anticoagulants may take two to four hours to wear off,thereby increasing the time required before completion of the manualcompression procedure.

Further, the manual compression procedure is uncomfortable for thepatient and frequently requires analgesics to be tolerable. Moreover,the application of excessive pressure can at times totally occlude theunderlying blood vessel, resulting in ischemia and/or thrombosis.Following manual compression, the patient typically remains recumbentfrom four to as much as twelve hours or more under close observation toassure continued hemostasis. During this time, renewed bleeding mayoccur, resulting in blood loss through the tract, hematoma and/orpseudo-aneurysm formation, as well as arteriovenous fistula formation.These complications may require blood transfusions and/or surgicalintervention.

The incidence of complications from the manual compression procedureincreases when the size of the introducer sheath grows larger, and/orwhen the patient is anticoagulated. The compression technique forarterial closure can be risky, and is expensive and onerous to thepatient. Although trained individuals can reduce the risk ofcomplications, dedicating such personnel to this task is both expensiveand inefficient. Nonetheless, as the number and efficacy oftranslumenally performed diagnostic and interventional vascularprocedures increase, the number of patients requiring effectivehemostasis for a vascular puncture continues to increase.

To overcome the problems associated with manual compression, the use ofbioabsorbable sealing bodies is another example approach that has beenproposed to achieve hemostasis. Generally, the use of bioabsorbablesealing bodies relies on the placement of a thrombogenic andbioabsorbable material, such as collagen, at the superficial arterialwall over the puncture site. While potentially effective, the use ofbioabsorbable material suffers from a number of drawbacks. For example,bioabsorbable sealing bodies may lack a solid mechanical attachment ofthe sealing body to the tissue. Due to the lack of a solid mechanicalattachment, the sealing body can wander within the tissue tract or moveout of the puncture site, thus causing late bleeds. Conversely, if thesealing body wanders and intrudes too far into the arterial lumen, dueto the lack of a solid mechanical attachment, intravascular clots and/orcollagen pieces with thrombus attached can form and embolize downstream,causing vascular occlusion.

In addition to not having a solid mechanical attachment to the tissue,the sealing bodies may rely upon expandable materials to achievehemostasis. Again, the expandable materials lack the security of a hardmechanical closure, thus potentially causing late bleeds and prolonginghemostasis.

A further approach to achieving hemostasis is to use a suture to close apuncture site. Although difficult to suture manually, suture applyingdevices can be used to appropriately place a suture for closing apuncture site. One example suture applying device has a shaft carrying apair of needles near its distal end. The needles are joined together bya length of suture. The shaft is used to introduce the needles into alumen of a body structure and the needles pushed back through the lumenwall on either side of a puncture site. After the needles have passedback through the tissue, they are captured on the shaft and drawnproximally away from the body structure. Drawing the needles outwardleaves a loop of suture behind to close the puncture site. The loop ofsuture can then be tied in a knot to complete the closure. Sutureapplying devices address many disadvantages associated with the use ofexternal force (e.g., digital compression and with the use ofbioabsorbable sealable bodies to achieve hemostasis.

However, the use of suture applying devices also has a number ofinefficiencies. Typically, to access a suture in a manner that it can betied off, the needle must be fully removed from the shaft and othercomponents subsequently moved out of the way. However, after needledeployment, suture applying devices are often configured to draw needlesproximally only to a point where they are partially exposed at theproximal end of the shaft. To remove needles from the shaft completely,an operator has to use manual force to individually grab the proximalend of each needle (e.g., with a hemostat) and draw it furtherproximally while also securely holding the shaft. The amount of forcerequired to further draw the needle proximally can sometimes be quitelarge (and potentially unacceptable).

Some suture applying devices have a separate internal needle holder thatcan be used to receive a partially exposed needle. The needle holderassists an operator in drawing the needle proximally until the distalend of the needle exits the proximal end of the shaft. However, needleholders often do not sufficiently grip a needle such that it can beefficiently drawn proximally. Additionally, the leverage obtained fromusing a needle holder is often insufficient to remove a needle fromchallenging (e.g., calcified or scarred) tissue anatomy.

For at least these reasons, it would be desirable to provide devices andmethods for more efficiently removing needles from a suture applyingdevice. It would be particularly desirable to provide devices andmethods for efficiently removing needles from a suture applying deviceused to suture a puncture site associated with a percutaneous vascularprocedure.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the invention relate generally to devices, systems, andmethods for removing needles from systems or devices used to closeopenings in body lumens. In an embodiment, a needle removal device mayinclude a base member configured to be selectively positionedsubstantially adjacent a proximal portion of a suturing system. Theproximal portion of the suturing system may include a plurality ofneedle lumens extending. The needle removal device may also include aplurality of needle receptacles at least partially defined by the basemember. The needle receptacles may be positioned and configured togenerally correspond to the needle lumens of the suturing device. Theneedle receptacles may be further configured to selectively receive andgrasp onto one or more needles extending proximally from the needlelumens of the suturing device.

In an embodiment, the base member may be at least semi-flexible and theneedle receptacles may be formed in a bottom surface of the base member.Grooves may be formed in an upper surface of the base member and may bein communication with the needle receptacles. A pair of tabs may beattached to opposite ends of the base member. The tabs may be configuredto move the needle removal element between a receiving position, whereinat least a portion of the needles are moveable within the needlereceptacles, and a grasping position, wherein the tabs flex the basemember such that the grooves grasp the needles between opposingsidewalls of the grooves to secure the needles within the needlereceptacles.

In another embodiment, the base member may comprise a generallycylindrical body and the needle receptacles extend at least partiallythrough the body. A plurality of slots that traverse at least a portionof the needle receptacles may be formed in a lateral surface of thebody. The needles may include notched portions configured and positionedto engage with the slots to lock the needles in the needle receptacles.

In an embodiment, a suture system may include a plurality of needles.One or more sutures may have an end attached to one of the needles. Thesystem may also include a guide body having a proximal end, a distalend, a central lumen, one or more suture lumens configured to receive atleast a portion of the one or more sutures, and a plurality of needlelumens configured to receive the needles. A shaft may be moveablypositioned within the guide body. The shaft may be operably connected tothe needles such that proximal movement of the shaft draws the needlesinto the needle lumens. The system may also include a needle removaldevice positioned substantially adjacent the proximal end of the guidebody. The needle removal device may include a base member and aplurality of needle receptacles generally corresponding to the pluralityof needle lumens. The needle removal device may be configured andpositioned to selectively receive and remove one or more of the needlesfrom the needle lumens.

In an embodiment, a method for removing one or more needles from asuturing system may include positioning a needle removal devicesubstantially adjacent a proximal end of the suturing system. The methodmay also include drawing the needles proximally through the suturingsystem until at least the tips of the needles exit from the proximal endof the suturing system. The tips of the needles may then be receivedwithin needle receptacles formed within the needle removal device. Theneedles may then be secured within the needle receptacles. Finally, theneedle removal device may be moved proximally relative to the suturingsystem to remove the needles from the suturing system.

These and other advantages and features of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify at least some of the advantages and features of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only illustrated embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1A illustrates a side perspective view of a suturing systemaccording to an embodiment;

FIG. 1B illustrates a detailed view of the needle guide of the suturingdevice of FIG. 1A taken along line 1B-1B.

FIG. 1C illustrates a cross-sectional view of the suturing system ofFIG. 1A taken along line 1C-1C.

FIG. 1D illustrates a top perspective view of the needle removal deviceremoved from the suturing system shown in FIG. 1A;

FIG. 1E illustrates a bottom perspective view of the needle removaldevice shown in FIG. 1D;

FIG. 1F illustrates a top perspective view of a needle removal deviceaccording to another embodiment;

FIGS. 2A-2D illustrate exemplary steps for removing needles from thesuturing device shown in FIG. 1A;

FIG. 3A illustrates a partial side perspective view of a suturing systemaccording to another embodiment;

FIG. 3B illustrates a perspective view of the needle removal deviceremoved from the suturing system shown in FIG. 3A;

FIG. 3C illustrates a cross-sectional view of the needle removal deviceshown in FIG. 3B taken along line 3C-3C;

FIGS. 4A-4B illustrate exemplary steps for removing needles from thesuturing system shown in FIG. 3A;

FIG. 5A is a partial side perspective view of a suturing systemaccording to another embodiment;

FIG. 5B is a perspective view of the needle removal device removed fromthe suturing system shown in FIG. 5A;

FIGS. 6A-6C illustrate exemplary steps for removing needles from thesuturing system shown in FIG. 5A with the needle removal device;

FIG. 7A is a partial side perspective view of a suturing systemaccording to another embodiment;

FIG. 7B is a perspective view of the needle removal device removed fromthe suturing system shown in FIG. 7A;

FIGS. 8A-8C illustrate exemplary steps for removing needles from thesuturing system shown in FIG. 7A with the needle removal device;

FIG. 9A is a partial side perspective view of a suturing systemaccording to another embodiment;

FIG. 9B is a perspective view of the needle removal device removed fromthe suturing system shown in FIG. 9A; and

FIGS. 10A-10C illustrate exemplary steps for removing needles from thesuturing system shown in FIG. 9A with the needle removal device.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As used herein, the term “distal” is generally defined as in thedirection of the patient or away from a user of a device. In the contextof a medical device intervention with or through a vessel wall, “distal”herein refers to the interior or the lumen side of the vessel wall.Conversely, “proximal” generally means away from the patient or towardthe user. In the context of a medical device intervention with orthrough a vessel wall, “proximal” herein refers to the exterior or outerside of the vessel wall.

The term “hemostasis” is herein used to mean the arrest of bleeding orsubstantially blocking flow of blood outwardly from a vessel lumen whilethe vessel lumen is pressurized or sustaining physiological blood flow.This amount of blockage or occlusion to flow is further defined suchthat the blood loss which is experienced is less than an amount whichwould affect procedural methods or outcomes according to a physicianuser of a device of ordinary skill in the art. In other words,“hemostasis” is not intended to mean only “total hemostasis” such thatthere is a total lack of blood loss. Rather, the term is used to alsomean “procedural hemostasis” as a relative term in its use amongphysicians of ordinary skill.

The term “suturing” is herein intended to include the process of joiningtwo surfaces or edges together with a suture such as a thread ofmaterial (either polymeric or natural), gut, wire, or the like or so asto close an aperture, opening, or wound, or join tissues.

Referring to FIG. 1A and FIG. 1B, a suturing system 10 may be providedto close openings in body tissues. The suturing system 10 may comprise aguide body 102, a needle guide 104 secured to a distal end of the guidebody 102, and a flexible tube 106 secured to a distal end of the needleguide 104. A plurality of needles 108 may be mounted with their distalends in a support holster (not shown) within the flexible tube 106. Inan embodiment, a moveable needle deployment shaft 112 (shown in FIG. 2B)may be operatively connected to the needles 108. For example, the needledeployment shaft 112 may be attached to the support holster and may bemoveably positioned within a central lumen 122 (shown in FIG. 1C) thatextends at least partially through the flexible tube 106, the needleguide 104, and the guide body 102. As shown further in regard to FIGS.2A-2D, the guide body 102 of the suturing system 10 may be introducedwithin a percutaneous tissue tract leading to a puncture site with theflexible tube 106 positioned within a vessel. When the needle deploymentshaft 112 is moved proximally relative to the guide body 102, theneedles 108 may be drawn proximally through the flexible tube 106, outthe needle guide 104 and toward the guide body 102. The needles 108 maycarry suture lengths 128 (shown in FIG. 1B) which may be used to closethe puncture site. As the needles 108 extend from the needle guide 104,the needles 108 may pass through tissue positioned between the needleguide 104 and the guide body 102. The guide body 102 may then capturethe needles 108 and route them toward the user.

A handle assembly 114 may be attached to a proximal end of the guidebody 102. The handle assembly 114 may include interlock wings 116, aneedle removal device 152, and a handle 118. The handle 118 may beattached to a proximal end of the needle deployment shaft 112 and can bepulled proximally in order to actuate the needle deployment shaft 112. Asheath 120 may also be rotatably received over the guide body 102. Thesheath 120 may be sized to be introducible through the percutaneoustissue tract. The sheath 120 may be inflexible or flexible and formed atleast partially from metal, a hard plastic or polymer material, or othersuitable materials.

As best shown in FIG. 1C, the guide body 102 may define one or moreaxial lumens or channels therein. For example, the central axial lumen122 may be provided for slidably receiving the needle deployment shaft112. The guide body 102 may also include one or more blood detectionlumens 124 and one or more suture lumens 126 that pass therethrough. Theone or more blood detection lumens 124 may be configured for receivingblood from the vessel to assist in positioning the suturing system 10.The one or more suture lumens 126 may be configured to receive thesuture lengths 128 attached to the needles 108. In other embodiments,the blood detection lumen 124 may be omitted.

The guide body 102 may further include a plurality of needle lumens 136.The needle lumens 136 may be axially aligned and circumferentiallyspaced about the periphery of the guide body 102. In other embodiments,the needle lumens 136 may be configured to extend through the guide body102. In yet other embodiments, the needle lumens 136 may be configuredto extend along paths wherein the needle lumens 136 exit along a singleside of the guide body 102 as described, for example, in U.S. PatentApplication entitled “Removing Needles from a Suturing Device,” Ser. No.13/610,595, filed on the same day, the disclosure of which isincorporated herein in its entirety. The needles 108 may enter thedistal ends of the needle lumens 136 after the needles 108 exit theneedle guide 104.

Referring again to FIG. 1A, the flexible tube 106 may be formed from aflexible plastic, polymer, metal, combinations thereof, or any othersuitable material. The flexible tube 106 may be generally circular incross-sectional geometry and may include a guide wire lumen (not shown)and the central lumen (not shown) configured to house the supportholster (not shown) and the needles 108. The flexible tube 106 mayfurther include a guide wire exit port 134 configured to allow a guidewire that is advanced proximally through a guide wire lumen (not shown)to exit from a side of the flexible tube 106. Optionally, the flexibletube 106 may include a distal J-tip 139 for atraumatic tracking throughvessels or other body lumens. In other embodiments, the distal J-tip 139may be omitted.

Construction of the handle assembly 114 will now be described. A stem138 (shown in FIG. 2B) may be formed between the interlock wings 116 forreceiving the handle 118. The stem 138 may include a key 130 that isreceived into a slot (not shown) in the handle 118. Such a configurationmay allow the handle 118 to be slid into the stem 138 with the key beingreceived into the slot. The handle 118 may be rotated in a clockwisedirection to secure the handle 118 to the stem and prevent axialtranslation of the needle deployment shaft 112. To move the needledeployment shaft 112 and deploy the needles 108, the handle 118 may berotated in a counter-clockwise direction so that the key may be pulledfrom the slot. The handle 118 may then be proximally moved to deploy theneedles 108.

The handle assembly 114 may be securely attached to the guide body 102so that the sheath 120 may be rotated relative to the guide body 102when holding the handle assembly 114. The handle assembly 114 may besecurely fastened to the guide body 102 by gluing, molding, and thelike. In other embodiments, the handle assembly 114 may be formed as anintegral part of the guide body 102. The handle assembly 114 may alsoinclude a plurality of tubes (not shown) aligned with the blooddetection lumen 124 and the one or more suture lumens 126. At least aportion of the suture lengths may pass through one or more of the tubes.

The interlock wings 116 may each include a detent 144 for engaging apair of grooves 146 in a hub 148 of the sheath 120. The interlock wings116 may be constructed of a resilient material (e.g., polycarbonate) sothat the interlock wings 116 may be pressed together to remove thedetents 144 from the grooves 146. Upon removal of the detents 144 fromthe grooves 146, the sheath 120 may be rotated relative to the guidebody 102 by maintaining a grip on the interlock wings 116 with one handand rotating the hub 148 with the other hand. In other embodiments, theinterlock wings 116 and the hub 148 may allow a physician or other userto hold and manipulate the suturing system 10. For example, thephysician can hold on to the hub 148 when inserting and withdrawing thesuturing system 10 from a puncture site.

Referring now to FIGS. 1A and 1C, the central lumen 122 may extend fromthe flexible tube 106, through the needle guide 104, through the guidebody 102 and into the stem 138 of the handle assembly 114. The needledeployment shaft 112 may run the length of the central lumen 122.Accordingly, the handle 118 may be proximally moved to move the needledeployment shaft 112 through the central lumen 122 which in turn movesthe needles 108. The one or more suture lumens 126 may run generallyparallel or non-parallel to the central lumen 122. The suture lengths128 may pass through the one or more suture lumens 126. In oneembodiment, the suture lengths 128 may be configured in the form of theloop with the free ends being attached to the needles 108 and with thelooped end passing outside the suturing system 10 through the tube (notshown). Such a configuration facilitates management of the suturelengths 128 during insertion of the suturing system 10 to a puncturesite and during movement of the needles 108 to suture the vessel wall.As the needles 108 are proximally advanced through the guide body 102,the suture lengths 128 are drawn distally through the suture lumen 126where they are completely removed from the suture lumen 126 upon fulldeployment of the needles 108 wherein the tips of the needles 108 exitthe hub 148 and are received by the needle removal device 152 positionedat the proximal end of the guide body 102. The needle removal device 152may be configured to selectively grasp or pinch the needles 108 exitingfrom the hub 148 and to draw the needles 108 proximally out of the guidebody 102 until the suture lengths 128 are available to a user to be tiedover the puncture site.

As shown in FIG. 1A, the needle removal device 152 may be positioned atleast partially within the hub 148. In other embodiments, the needleremoval device 152 may be selectively positioned distally or proximallyof the hub 148.

FIGS. 1D and 1E show the needle removal device 152 removed from thesuturing system 10. The needle removal device 152 may include a baseportion 156 and a pair of tabs 164 attached at opposite ends of the baseportion 156. The needle removal device 152 may be made from polymers,polymeric composites, titanium, stainless steel, metal alloys,combinations thereof, or any other suitable materials. As shown, acentral aperture 154 may be formed in the base portion 156. The centralaperture 154 may be configured to allow the stem 138 of the handleassembly 114 to pass through the base portion 156 such that the needleremoval device 152 may be selectively positioned between the guide body102 and the handle 118. The central aperture 154 may also be configuredto receive the needle deployment shaft 112 such that the needledeployment shaft 112 may selectively be drawn through the needle removaldevice 152. Such a configuration allows the needle deployment shaft 112and the needle removal device 152 to move axially relative to oneanother.

In another embodiment, the needle removal device 152 may further includea disengagement slot 158 extending between the aperture 154 and a firstside surface 156A of the base portion 156. The disengagement slot 158may be configured to help the needle removal device 152 to beselectively removed from the needle deployment shaft 112. In otherembodiments, the disengagement slot 158 may be omitted.

As shown, a pair of grooves 160 may be formed in an upper surface of thebase portion 156. Each of the grooves 160 may include a bottom portionand opposing sidewalls. As illustrated in FIG. 1D, the grooves 160 maybe substantially linear and parallel to one another. In otherembodiments, the grooves 160 may be substantially non-linear and/ornon-parallel to one another. As shown, each of the grooves 160 may havea length that extends along an axis of the groove 160 between the firstside surface 156A and a second side surface 156B of the base portion156. In other embodiments, the length of one or more of the grooves 160may extend only partially between the first side surface 156A and thesecond side surface 156B.

As shown, each of the grooves 160 may also have a depth extendingbetween the upper surface of the base portion 156 and the bottom portionof the groove 160. In another embodiment, the depth of one or more ofthe grooves 160 may be constant. In other embodiments, the depth of oneor more of the grooves 160 may vary. For example, the one or more of thegrooves 160 may include a deeper portion and a shallower portion. Thedepth of one or more of the grooves 160 may be about twenty five (25)percent to ninety five (95) percent; about thirty five (35) percent toeighty five (85) percent; about forty five (45) percent to seventy five(75) percent of a thickness of the base portion 156 defined between theupper and lower surfaces of the base portion 156. In other embodiments,the depth of one or more grooves 160 may be larger or smaller relativeto the thickness of the base portion 156.

Each of the grooves 160 may also include a width extending between theopposing sidewalls of the groove 160. The opposing sidewalls may besubstantially planar and perpendicular to the bottom surface of the baseportion 156. In other embodiments, the sidewalls may be substantiallynon-perpendicular to the bottom surface of the base portion 156. Inother embodiments, the sidewalls may be substantially non-planar,concavely curved, or have other suitable configurations. In otherembodiments, the width of the grooves 160 may be constant along thelength of the grooves 160. In yet other embodiments, the width of thegrooves 160 may vary along the length of the grooves 160. For example,the grooves 160 may include narrower and wider portions.

As shown in FIG. 1D, a plurality of needle receptacles 162 may be formedin the base portion 156. The needle receptacles 162 may extend betweenthe bottom surface of the base portion 156 and the bottom portion of thegrooves 160. One or more of the needle receptacles 162 may have agenerally cylindrical geometric shape, generally conical geometricshape, generally oval geometric shape, or any other suitable geometricshape. The needle receptacles 162 may be configured and positioned inthe base portion 156 to generally correspond to the needle lumens 136exiting the proximal end of the guide body 102. Such a configurationallows the needles 108 to be selectively received within the needlereceptacles 162 when the needles 108 exit the needle lumens 136 of theguide body 102. While four needle receptacles 162 are shown surroundingthe central aperture 154, three, five, six, or any other suitable numberof needle receptacles 162 may be formed in the base portion 156 in anysuitable configuration.

At least a portion of the base portion 156 may be formed of one or moresemi-flexible materials such as polymers, polymeric composites, metals,combinations thereof, or the like. As explained in more detail below,configuring the base portion 156 in this manner may allow the needleremoval device 152 to move between a receiving position, wherein atleast a portion of each needle 108 can pass through the needlereceptacles 162 and the grooves 160, and a grasping position, whereinthe grooves 160 grasp or pinch the needles 108 between the opposing sidewalls of the grooves 160. Such a configuration may allow a user to exerta force in the proximal direction on the needles 108 to overcome aninitial resistance to removal of the needles 108 from the guide body102. For example, in the grasping position, the needle removal device152 may allow a user to exert a force in the proximal direction of aboutone quarter (0.25) pound-force to seventy (70) pound-force; about one(1) pound-force to sixty (60) pound-force; or about five (5) pound-forceto forty (40) pound-force on the needles 108 to overcome an initialresistance to proximal movement of the needles 108 from the guide body102. In other embodiments, the needle removal device 152 may allow auser to exert larger or smaller forces on the needles 108. At least aportion of the sidewalls of the grooves 160 may include grippingfeatures such as ridges, textured surfaces, adhesives, magnets, or otherfeatures suitable to help grip the needles 108 in the grooves 160. Inother embodiments, the gripping features may be omitted.

Referring still to FIGS. 1D-1F, the tabs 164 may be configured to movethe needle removal device 152 between the receiving and graspingpositions. As shown, the tabs 164 may be integral to the base portion156. In other embodiments, the tabs 164 may be connected to the oppositeends of the base portion 156 via adhesives, threaded attachment,fastening with a fastener, welding, combinations of the foregoing, oranother suitable technique. The tabs 164 may be generally elongatedrectangles and extend proximally from the base portion 156. The tabs 164may have a height defined between the top surface of the base portion156 and a proximal end of the tabs 164. The base portion 156 may have alength defined between the opposite ends of the base portion 156. Theheight of the tabs 164 may be greater or smaller than the length of thebase portion 156. The height of one or more of the tabs 164 may be aboutthirty (30) percent to one hundred fifty (150) percent; about forty (40)percent to one hundred forty (140) percent; about 50 percent to onehundred thirty (130) percent; about sixty (60) percent to one hundredtwenty (120) percent; about seventy (70) percent to one hundred ten(110) percent the length of the base portion 156. In other embodiments,the height of one or more of the tabs 164 may be more or less relativeto the length of the base portion 156.

During use of the needle removal device 152, a user may squeeze proximalfree end portions of the tabs 164 together to move the needle removaldevice 152 from the receiving position to the grasping position. Thismay be done with the user's hand, a tool, or by any other suitablemeans. The tabs 164 may function as moment arms to flex or bow the baseportion 156 of the needle removal device 152. As the tabs 164 flex thebase portion 156, the needle removal device 152 may move toward thegrasping position, wherein the grooves 160 grasp or pinch the needles108 between the opposing side walls of the grooves 160. With the needleremoval device 152 in the grasping position, the user may release theproximal free end portions of the tabs 164 to allow the tabs 164 toreturn to a resting position. In the resting position, the base portion156 may relax and the needle removal device 152 may move back toward thereceiving position. As shown, such a configuration of the needle removaldevice 152 may position the tips of the needles 108 between the tabs 164such that the risk of injury to a user or patient is reduced.

As shown, the tabs 164 may include a substantially planar inner surfaceand a substantially concavely curved outer surface. In otherembodiments, the inner and/or outer surface of the tabs 164 may begenerally planar, contoured, concavely curved, convexly curved,contoured, irregular, or any other suitable configuration. For example,the outer surface of the tabs 164 may include a tool indentationconfigured to selectively receive a distal portion of a hemostat orother medical instrument. In other embodiments, the outer surface of thetabs 164 may include gripping features configured to help a user squeezethe proximal free end portions of the tabs 164 together. For example,the outer surface of the tabs 164 may include a textured surfaceconfigured as a grip for a user's fingers. In other embodiments, theouter surface of the tabs 164 may include ridges, ergonomicalindentations, or the like.

While the tabs are as illustrated being generally elongated rectangles,the tabs may be generally oval, generally triangular, generallydiamond-like, irregularly shaped, or any other suitable shape. Forexample, as shown in FIG. 1F, the tabs 164 may be configured similarlyto the interlock wings 116. The tabs 164 may include generallytrapezoidal distal portions connected to the opposite ends of the baseportion 156. The distal portions of the tabs 164 may be angled relativeto the base portions 156. The tabs 164 may also have a substantiallywing-like proximal free end portion angled relative to the distalportion of the tabs 164. In other embodiments, the tabs 164 may includeelongated slots 166 extending therethrough and along an axis of the tabs164 to generally correspond to a support structure formed on an innersurface of the interlock wings 116. In other embodiments, the elongatedslots may be omitted from the tabs 164. For example, the tabs 164,without elongated slots, may be positioned on the suturing system 10such that the tabs 164 are rotated ninety (90) degrees relative to theinterlock wings 116.

FIGS. 2A through 2D illustrate steps for removing needles from thesuturing device 10 with the needle removal device 152. While the methodis illustrated using the suturing system 10, it will be appreciated thatthe described method may utilize any other suturing system or systemdisclosed herein. Moreover, for ease of reference, one of the interlockwings 116 has been removed from the suturing system 10.

Referring now to FIG. 2A, the method can begin by advancing the suturingsystem 10 through an access tract 270 to position the needles 108encased by the flexible tube 106 within the vessel 268 past the puncturesite 266. In other embodiments, the suturing system 10 may be introducedover a guide wire (not shown) passing through the vessel 268. Forexample, an introducer sheath (not shown) may be placed over a guidewire passing percutaneously beneath the patient's skin. The introducersheath may then be withdrawn from the puncture site 266 by sliding theintroducer sheath over the guide wire. The suturing system 10 may thenbe introduced over the guide wire by passing the guide wire proximallythrough the flexible tube 106 until the guide wire exits the exit port134 (shown in FIG. 1A). The flexible tube 106 may then be furtheradvanced over the guide wire until the needle guide 104 is about toenter the access tract 270. At this point, the guide wire is pulled fromthe flexible tube 106 and is withdrawn from the puncture site 266. Withthe guide wire removed, the suturing system 10 may be further advancedinto the vessel 268 to pass the needle guide 104 through the accesstract 270 into the vessel 268.

Referring now to FIG. 2B, to deploy the needles 108, the handle 118(shown in FIG. 2A) may be drawn proximally relative to the guide body102 to proximally move the needle deployment shaft 112. In otherembodiments, the handle 118 may be rotated counter-clockwise todisengage the key from the slot in the stem 138 prior to drawing thehandle 118 proximally. As shown, the needles 108 will exit from theneedle guide 104, pass through the vessel wall 272, and will be directedtoward the needle lumens 136 of the guide body 102. As the needles 108are drawn through the vessel wall 272, the suture lengths 128 will befed distally through the one or more suture lumens 126 (shown in FIG.1C). The needles 108 will then be advanced into the needle lumens 136,with the suture lengths 128 being continually fed through the one ormore suture lumens 126. The handle 118 may continue to be drawnproximally (i.e., outward from the patient) in order to continue to pullthe needles 108 through the guide body 102. Such movement of the needles108, in turn, continues to draw the needles 108 proximally through theneedle lumens 136 of the guide body 102 until the needles 108, with thesuture lengths 128 still attached thereto, exit the hub 148 and arereceived within the needle receptacles 162 and/or the grooves 160 of theneedle removal device 152 as shown in FIG. 2B. At that point, the loopedportions of the suture lengths 128 may be removed from the one or moresuture lumens 126.

Referring now to FIG. 2C, the proximal free end portions of the tabs 164may be squeezed or pushed together (i.e., moved to the actuatedposition) to flex the base portion 156 such that the needle removaldevice 152 moves to the grasping position. The tabs 164 may be squeezedor pushed together with a user's fingers, a hemostat, or any othersuitable means. In the grasping position, the needles 108 may be graspedby the needle removal device 152 between the opposing sidewalls of thegrooves 160. In other embodiments, the sidewalls of the grooves 160 mayinclude gripping features configured to help grasp the needles 108 suchas ridges, textured surfaces, magnets, or other suitable means.

Referring now to FIG. 2D, with the needle removal device 152 in thegrasping position, the needle removal device 152 may be moved proximallyrelative to the guide body 102. Proximal movement of the needle removaldevice 152, in turn, may continue to remove the needles 108 from theguide body 102 until the suture lengths 128 are available to the user.Once the needles 108 are removed from the guide body 102, slack may beremoved from the suture lengths 128 by pulling them to evenly matchedlengths and tensioning until resistance is felt. The suture lengths 128may then be cut substantially close to the needles 108 and the needles108 may be disposed of. The suturing system 10 may then be removed fromthe access tract 270 to allow closure of the puncture site 266. Such aconfiguration of the suturing system 10 may allow a user to safely andsecurely close a puncture site.

In other embodiments, the suturing system 10 may be readily adapted foruse with punctures made to a variety of hollow body organs and lumens.It may, however, be necessary to modify the dimensions and otherparticular aspects of the suturing system 10 to accommodate thedifferent usage environments. For example, the distance between theneedle guide 104 and the guide body 102 may be configured to allowtransapical insertion of the suturing system 10 into a heart ventricleas described in U.S. Patent Application, entitled “Apparatus and Methodfor Suturing Body Lumens,” Ser. No. 13/443,659, the disclosure of whichis incorporated herein in its entirety.

Another embodiment of a needle removal device will now be described inrelation to FIGS. 3A through 4B. A suturing system 30 may be similar inmany respects to the suturing system 10 previously described above inFIGS. 1A-2D. To the extent features or components of this configurationfunction in a manner similar to that as described above, such disclosureis hereby incorporated into the following additional configuration. Likestructures and/or components are given like reference numerals. For easeof reference, only the proximal portion of the suturing system 30 isshown and described. The distal components may be manipulated by theproximal components in a similar manner as described with references toFIGS. 1A through 2D.

FIG. 3A is a partial side perspective view of the suturing system 30.The suturing system 30 may include a guide body 302, a needle guide (notshown) secured to a distal end of the guide body 302, and a flexibletube (not shown) secured to a distal end of the needle guide. A sheath320 may be rotatably received over the guide body 302. A plurality ofneedles 308 (shown in FIG. 4A) may be mounted with their distal ends ina support holster (not shown) and attached to a movable needledeployment shaft 312 (shown in FIG. 4A). A handle assembly 314 may beattached to a proximal end of the guide body 302. The handle assembly314 may include a pair of interlock wings 316, a needle removal device352, and a handle 318. The handle 318 may be attached to a proximal endof the needle deployment shaft 312 and may be pulled proximally in orderto draw the needles 308 from the flexible tube, through the needle guideand into the guide body 302 until the tips of the needles 308 emergefrom the guide body 302 within a hub 348 of the sheath 320. Once theneedles 308 emerge within the hub 348, the needles 308 may be receivedby the needle removal device 352.

FIG. 3B is an isometric view of the needle removal device 352 removedfrom the suturing system 30. As shown, the needle removal device 352 mayinclude a generally cylindrical body 372 and a handle portion 376. Theneedle removal device 352 may be made from polymers, polymericcomposites, titanium, stainless steel, metal alloys, combinationsthereof, or any other suitable materials.

The body 372 may include a central aperture 354 extending therethroughconfigured to allow a stem 338 (shown in FIG. 4B) of the handle assembly314 to pass through the body 372. The central aperture 354 may also beconfigured to receive the needle deployment shaft 312 such that theneedle deployment shaft 312 may selectively be drawn through theaperture 354 of the needle removal device 352. Accordingly, the needledeployment shaft 312 and the needle removal device 352 may be configuredto move axially relative to one another. The needle removal device 352may be positioned at least partially within the sheath hub 348. In otherembodiments, the needle removal device 352 may be positioned proximalthe sheath hub 348 or substantially within the sheath hub 348.

The body 372 may include a plurality of needle receptacles 362 formed ina bottom surface of the body 372. The needle receptacles 362 may atleast partially define lumens extending through the bottom surface ofthe body 372 toward an upper surface of the body 372. The lumen of theneedle receptacles 362 may have a circular, oval, triangular, or othersuitable cross-sectional geometric shape. The lumens of one or more ofthe needle receptacles 362 may have a constant diameter or a varyingdiameter. The needle receptacles 362 may be configured and positioned inthe body 372 to generally correspond to needle lumens 336 (shown in FIG.3A) exiting the proximal end of the guide body 302. Such a configurationmay allow the needles 308 to be selectively received within the needlereceptacles 362 when the needles 308 exit the guide body 302 through theneedle lumens 336. As shown, four needle receptacles 362 may be formedin the body 372 about the central aperture 354. In other embodiments,three, five, six, or any other suitable numbers of needle receptacles362 may be formed in the body 372 in any suitable configuration.

As shown in FIG. 3B, the body 372 may include a plurality of slots 374formed in a side surface of the body 372. The slots 374 may traverse oneor more of the needle receptacles and form a locking edge 374Aconfigured to lock the needles 308 in the needle receptacles 362. Asshown, the body 372 may include two pairs of opposing slots 374. Inother embodiments, the body 372 may include one, two, three, five, orany other number of slots configured in any suitable configuration. Inother embodiments, one or more of the slots 374 may be filled withsecuring materials such as adhesives, epoxy, or other securing materialsconfigured to help lock the needles 308 in the needle receptacles 362.In other embodiments, the securing materials may be omitted.

Referring still to FIG. 3B, the handle portion 376 may be attached tothe upper surface of the body 372. The handle portion 376 may beconfigured to provide a user a grip to manipulate the needle removaldevice 352. The handle portion 376 may be integral to the body 372 orthe handle portion 376 may be attached to the body 372 via adhesives,threadedly attaching, fastening with a fastener, welding, combinationsof the foregoing, or another suitable technique. The central aperture354 may also extend through the handle portion 376 such that the needledeployment shaft 312 may pass through the handle portion 376.

In other embodiments, the handle portion 376 may be configured to rotaterelative to the body 372 such that the needle removal device 352 may beselectively locked on the stem 338. For example, the handle portion 376may include a shaft portion (not shown) attached thereto that extendsthrough the central aperture 354 between the stem 338 and the body 372.The shaft portion may include a rib feature at a distal end configuredto maintain the shaft portion within the body 372. In other embodiments,the shaft portion may include a key (not shown) that is received withina slot (not shown) in the stem 338. Such a configuration may allow theneedle removal device 352 to be slid over the stem 338 with the keybeing received in the slot. The handle portion 376 of the needle removaldevice 352 may be rotated in a clockwise direction to rotate the shaftportion to secure the needle removal device 352 to the stem 338 in orderto prevent axial movement of the needle removal device 352. To move theneedle removal device 352 axially, the handle portion 376 of the needleremoval device 352 may be rotated in a counter-clockwise direction sothat the key may be pulled from the slot. The needle removal device 352may then be moved proximally. In other embodiments, the handle portion376 and the shaft portion may be omitted from the needle removal device352.

FIG. 3C is a cross sectional view of the needle removal device 352 withthe needles 308 inserted in the needle receptacles 362. As shown, theneedles 308 may include notches 378 formed in a shaft portion of theneedles 308. The notches 378 may be formed circumferentially about theshaft portion, on one side of the shaft portion, or in any other part ofthe shaft portion of the needles 308. The notches 378 may be configuredto selectively lock on the locking edge 374A of the slots. For example,once the needles 308 are received within the needle receptacles 362, thelocking edges may engage the notches 378 of the needles 308. Onceengaged, the needles 308 are locked in the needle receptacles 362. Sucha configuration may allow a user to remove the needles 308 from theguide body 302.

Referring still to FIG. 3C, the needle receptacles 362 may have aproximal end located within a solid portion of the body 372 such thatthe tips of the needles 308 may be housed within the body 372 tosafeguard against accidental sticks.

FIGS. 4A and 4B illustrate exemplary steps in a method for removing theneedles 308 from the suturing system 30 with the needle removal device352. While the method is illustrated using the suturing system 30 andthe needle removal device 352, it will be appreciated that the describedmethod may utilize any other needle removal device and/or suturingsystem disclosed herein. Only certain exemplary steps of removing theneedles 308 from the suturing system 30 are shown and described,however, it will be appreciated that the method may follow delivery ofneedles and suture lengths through body tissue or a vessel wall by thesuturing system 30. For example, the method may include any of the stepspreviously described and/or illustrated in relation to FIGS. 2A through2E.

Referring now to FIG. 4A, to deploy the needles 308, the handle 318(shown in FIG. 3A) may be drawn proximally relative to the guide body302 to proximally move the needle deployment shaft 312. As shown, theneedle deployment shaft 312 may draw the needles 308 proximally throughthe needle lumens 336 of the guide body 302 until the needles 308 exitthe guide body 302 within the hub 348. As the needles 308 exit the guidebody 302, they may be received within the needle receptacles 362 of theneedle removal device 352 as shown. Once the needles 308 are receivedwithin the needle receptacles 362, the locking edges of the slots 374may engage the notches 378 (shown in FIG. 3C) in the needles 308. Such aconfiguration may substantially lock the needles 308 in the needlereceptacles 362. As shown, the tips of the needles 308 may be safelyhoused in the solid portion of the body 372 such that risk of injury toa user or patient from the tips of the needles 308 is reduced.

Referring now to FIG. 4B, with the needles 308 locked in the needlereceptacles 362, the needle removal device 352 may be drawn proximallyto pull the needles 308 out of the guide body 302. Once the needles 308are removed from the guide body 302, suture lengths (not shown) attachedto the needles 308 may be cut and the needles 308 may be disposed of.Such a configuration of the needle removal device 352 may allow a userto safely and quickly remove the needles 308 from the suturing system30.

Another embodiment of a needle removal device will now be described inrelation to FIGS. 5A through 6C. A suturing system 50 may be similar inmany respects to the suturing system 10 and the suturing system 30previously described above in FIGS. 1A-4B. To the extent features orcomponents of this configuration function in a manner similar to that asdescribed above, such disclosure is hereby incorporated into thefollowing additional configuration. Like structures and/or componentsare given like reference numerals. Similar to suturing system 30, forease of reference, only the proximal portion of the suturing system 50is shown and described. The distal components may be manipulated by theproximal components in a similar manner as described with reference toFIGS. 1A through 2D.

FIG. 5A is a partial side perspective view of the suturing system 50.The suturing system 50 may include a guide body 502, a needle guide (notshown) secured to a distal end of the guide body 502, and a flexibletube (not shown) secured to a distal end of the needle guide. A sheath520 may be rotatably received over the guide body 502. A plurality ofneedles 508 (shown in FIG. 6A) may be mounted with their distal ends ina support holster (not shown) and attached to a movable needledeployment shaft 512 (shown in FIG. 6A). A handle assembly 514 may beattached to a proximal end of the guide body 502. The handle assembly514 may include a pair of interlock wings 516, a needle removal device552, and a handle 518. The handle 518 may be attached to a proximal endof the needle deployment shaft 512 and may be pulled proximally in orderto draw the needles 508 from the flexible tube, through the needle guideand into the guide body 502 until the needles 508 emerge from the guidebody 502 within a hub 548. Once the needles 508 emerge within the hub548, the needles 508 may be received within the needle removal device552. While one needle removal device 552 is shown, the suturing system50 may include two, three, or any suitable number of needle removaldevices 552. For example, the suturing system 50 may include two needleremoval devices 552 located on opposites sides of the guide body 502such that a total of four needles may be received within the needleremoval devices 552 on the opposite sides of the guide body 502.

FIG. 5B is an isometric view of the needle removal device 552 removedfrom the suturing system 50. As shown, the needle removal device 552 mayinclude a base member 580, an attachment ring 582, and a pivoting member584. The needle removal device 552 may be formed from polymers,polymeric composites, titanium, stainless steel, combinations thereof,or any other suitable materials.

The base member 580 may include a pair of base support arms 586 and abase cross member 588. The base support arms 586 may have proximalportions attached to opposite ends of the base cross member 588 and theattachment ring 582. In other embodiments, the base support arms 586 maybe attached to the guide body 502, the hub 548, or any other suitablepart of the suturing system 50. As shown, the attachment ring 582 mayinclude a pair of attachment arms 590 configured to selectively attachthe needle removal device 552 to a stem 538 (shown in FIG. 6A) proximalto the guide body 502. As shown, the attachment arms 590 may form atleast a portion of circle having a diameter configured to generallycorrespond to an outer diameter of the stem 538. The attachment arms 590may be configured to flex apart such that the attachment ring 582 may beremovably attached to the stem 538 by moving the attachment ring 582 ina direction substantially traverse to the stem 538. In otherembodiments, the attachment arms 590 may be resiliently biased,substantially rigid, or they may have any other configuration suitableto attach and remove the attachment ring 582 from the stem 538.

Similar to the base member 580, the pivoting member 584 may include apair of pivoting support arms 592 and a pivoting cross member 594. Thepivoting support arms 592 may have proximal portions attached toopposite ends of the pivoting cross member 594 and distal portionspivotally connected to distal portions of the base support arms 586. Thepivoting support arms 592 may pivot about one or more pivot pins 596inserted through one or more apertures extending through the distalportions of the pivoting support arms 592 and the base support arms 586.In other embodiments, the pivoting support arms 592 may be pivotallyconnected to the base support arms 586 via a ball and joint typeconnection, a pivoting hinge connection, or any other suitable pivotingconnection.

The needle removal device 552 may be moveable between a receivingposition, wherein the base member 580 and the pivoting member 584 aremoved apart such that needles 508 (shown in FIG. 6A) may extendtherebetween, and a grasping position, wherein the base member 580 andthe pivoting member 584 are moved together to the grasp or pinch needles508 between the base member 580 and the pivoting member 584.

As shown, the needle removal device 552 may include one or more needlereceptacles 562 configured to receive the needles 508. The one or moreneedle receptacles 562 may be defined at least partially as the regionbetween the pivoting cross member 594 and the base cross member 588. Theone or more needle receptacles 562 may be configured and positioned togenerally correspond to needle lumens 536 at the proximal end of theguide body 502. Such a configuration may allow the needles 508 to bereceived within the needle receptacles 562 when the needles 508 exit theneedle lumens 536. The one or more needle receptacles 562 may includegrasping portions formed between the pivot cross member 594 and the basecross member 588. In other embodiments, the grasping portions mayinclude one or more gripping features such as ridges, textured surfaces,contoured surfaces, adhesive, magnets, or other features suitable toenhance the grip of the needle removal device 552 on the needles 508. Inaddition, the base member 580 and/or the pivoting member 584 may besubstantially rigid to improve compliance of the needle removal device552 and to enhance the grip of the needle removal device 552 on theneedles 508. Such a configuration may allow a user to exert a force inthe proximal direction on the needles 508 to overcome an initialresistance to removal of the needles 508 from the guide body 502. Forexample, in the grasping position, the needle removal device 552 mayallow a user to exert a force in the proximal direction of about onequarter (0.25) pound-force to seventy (70) pound-force; about one (1)pound-force to sixty (60) pound-force; or about five (5) pound-force toforty (40) pound-force on the needles 508. In other embodiments, theneedle removal device 552 may allow a user to exert larger or smallerforces on the needles 508.

The needle removal device 552 may include a pair of tabs 598. The tabs598 may be connected to the base cross member 588 and the pivoting crossmember 594, respectively. The tabs 598 may be integral to the crossmembers 588, 594 or the tabs 598 may be connected to the cross members588, 594 via adhesives, threadedly attaching, fastening with a fastener,welding, combinations of the foregoing, or another suitable technique.The tabs 598 may be configured to allow a user to move the needleremoval device 552 between the receiving and grasping positions. Forexample, a user may push or squeeze the tabs 598 together to move theneedle removal device 552 toward the grasping position. The user maypush or squeeze the tabs 598 together with a user's fingers, a hemostat,or other suitable means.

The needle removal device 552 may include locking features configured toselectively lock the needle removal device 552 in the grasping position.For example, one of the tabs 598 may include one or more locking armsconfigured to rotate over the other tab 598 when the needle removaldevice 552 is in the grasping position to hold the tabs 598 together.The other tab 598 may include one or more grooves configured to receiveand/or secure the one or more locking arms on the other tab 598. Inother embodiments, the locking features may include a hook memberconfigured to hold the tabs 598 together in the grasping position. Inother embodiments, the locking features may be omitted.

FIGS. 6A through 6C illustrate exemplary steps in a method for removingthe needles 508 from the suturing system 50 with the needle removaldevice 552. While the method is illustrated using the suturing system 50and the needle removal device 552, it will be appreciated that thedescribed method may utilize any other needle removal device and/orsuturing system disclosed herein. Only certain exemplary steps ofremoving the needles 508 from the suturing system 50 are shown anddescribed, however, it will be appreciated that the method may followdelivery of needles and suture lengths through body tissue or a vesselwall by the suturing system 50. For example, the method may include anyof the steps previously described and/or illustrated in relation toFIGS. 2A through 2D.

Referring now to FIG. 6A, to deploy the needles 508, the handle 518(shown in FIG. 5A) may be drawn proximally relative to the guide body502 to proximally move the needle deployment shaft 512. As shown, theneedle deployment shaft 512 may draw the needles 508 proximally throughthe needle lumens 536 of the guide body 502 until the needles 508 exitthe guide body 502 within the hub 548. As the needles 508 exit the guidebody 502, the needles 508 may be received within the needle receptacles562 while the needle removal device 552 is in the receiving position asshown.

Referring now to FIG. 6B, the tabs 598 may be squeezed or pushedtogether to move the needle removal element 552 into the graspingposition. The tabs 598 may be squeezed or pushed together with a user'sfingers, a hemostat, or any other suitable means. In the graspingposition, the needles 508 may be grasped or pinched by the needleremoval device 552 between the pivoting cross member 594 and the basecross member 588 in the grasping portions. The grasping portions mayinclude gripping features configured to help grasp the needles 508 suchas adhesives, ridges, textured surfaces, magnets, or other suitablemeans.

Referring now to FIG. 6C, with the needle removal device 552 in thegrasping position, the needle removal device 552 may be moved proximallyrelative to the guide body 502. The attachment ring 582 may be removedfrom the stem 538 by moving the attachment ring 582 axially orsubstantially traverse relative to the stem 538. Proximal movement ofthe needle removal device 552, in turn, may continue to remove theneedles 508 from the guide body 502. Once the needles 508 are removedfrom the guide body 502, suture lengths (not shown) attached to theneedles 508 may be cut and the needles 508 may be disposed of.

Such a configuration of the needle removal device 552 may allow a userto safely and efficiently remove the needles 508 from the suturingsystem 50.

Another embodiment of a needle removal device will now be described inrelation to FIGS. 7A through 8C. A suturing system 70 may be similar inmany respects to the suturing systems 10, 30, and 50 previouslydescribed above in FIGS. 1A-6C. To the extent features or components ofthis configuration function in a manner similar to that as describedabove, such disclosure is hereby incorporated into the followingadditional configuration. Like structures and/or components are givenlike reference numerals. Similar to suturing systems 30 and 50, for easeof reference, only the proximal portion of the suturing system 70 isshown and described. The distal components may be manipulated by theproximal components in a similar manner as described with reference toFIGS. 1A through 2D.

FIG. 7A is a partial side perspective view of the suturing system 70.The suturing system 70 may include a guide body 702, a needle guide (notshown) secured to a distal end of the guide body 702, and a flexibletube (not shown) secured to a distal end of the needle guide. A sheath720 may be rotatably received over the guide body 702. A plurality ofneedles 708 (shown in FIG. 8A) may be mounted with their distal ends ina support holster (not shown) and attached to a moveable needledeployment shaft 712 (shown in FIG. 8A). A handle assembly 714 may beattached to a proximal end of the guide body 702. The handle assembly714 may include a pair of interlock wings 716, a needle removal device752, and a handle 718. The handle 718 may be attached to a proximal endof the needle deployment shaft 712 and may be pulled proximally in orderto draw the needles 708 from the flexible tube, through the needle guideand into the guide body 702 until the needles 708 emerge from the guidebody 702 within a hub 748. Once the needles 708 emerge within the hub748, the needles 708 may be received within the needle removal device752. The needle removal device 752 may be location proximal to the hub748. In another embodiment, the needle removal device 752 may include alower surface configured to substantially mate with an upper surface ofthe hub 748 (best shown in FIGS. 8A and 8B).

FIG. 7B is an isometric view of the needle removal device 752 removedfrom the suturing system 70. As shown, the needle removal device 752 mayinclude a base member 756, guide members 780 connected to the basemember 756, and a pair of sliding members 782 slidably positioned on theguide members 780. The needle removal device 752 may be made frompolymers, polymeric composites, metals, combinations thereof, or anyother suitable material.

The base member 756 may include a central aperture 754 extendingtherethrough. The central aperture 754 may be configured to allow a stem738 (shown in FIG. 8A) of the handle assembly 714 to pass through thebase member 756 such that the needle removal device 752 may beselectively positioned between the guide body 702 and the handle 718.The central aperture 754 may also be configured to receive the needledeployment shaft 712 such that the needle deployment shaft 712 may beselectively drawn through the base member 756 of the needle removaldevice 752. Such a configuration may allow the needle deployment shaft712 and the needle removal device 752 to move axially relative to oneanother. The base member 756 may have a thickness similar to a thicknessof the sliding members 782. In other embodiments, the base member 756may have a thickness more or less than the thickness of the slidingmembers 782.

Each of the guide members 780 may be attached to a bottom surface of thebase member 756. In other embodiments, the guide members 780 may beattached to and extend from side surfaces of the base member 756. Asshown, the guide members 780 may be disposed generally traverse thebottom surface of the base member 756.

Each of the sliding members 782 may be slidably positioned on one ormore of the guide members 780 such that the sliding member 782 may movetoward and away from the base member 756. The sliding members 782 mayhave a generally semi-cylindrical geometric shape, a generally semi-ovalgeometric shape, a generally rectangular geometric shape, a generallytriangular geometric shape or any other suitable geometric shape. Thesliding members 782 may also include gripping portions 788 on a portionof the periphery of the sliding members 782 configured to provide a userwith a grip to manipulate the sliding members 782.

The needle removal element 752 may be moveable between a receivingposition, wherein the sliding members 782 and the base member 756 areslid apart such that needles 708 (shown in FIG. 8A) may extendtherebetween, and a grasping position, wherein the sliding members 782and the base member 756 are slid together to grasp or pinch needles 708between the sliding members 782 and the base member 756. In otherembodiments, the guide members 780 may include one or more resilientmembers (not shown) configured to bias the needle removal element 752toward the receiving position. Such a configuration may allow a user tosqueeze or push the sliding members 782 toward each other along theguide members 780 to move the needle removal element 752 toward thegrasping position. The user may push or squeeze the sliding members 782together with a user's fingers, a medical instrument, or other suitablemeans. To return the needle removal device 752 to the receivingposition, the user can simply release the sliding members 782 and theone or more resilient members will move the sliding members 782 awayfrom the base member 756.

The needle removal device 752 may include locking features configured toselectively lock the needle removal device 752 in the grasping position.For example, the sliding members 782 may include a plurality of teeth(not shown). The guide members 780 may include a plurality of teeth (notshown) configured to interlock with one or more of the teeth of thesliding members 782 when the needle removal device 752 is in thegrasping position. Such a configuration may allow a user to convenientlyand beneficially lock the needle removal device 752 in the graspingposition. In other embodiments, the locking features may include one ormore detents formed in the sliding members 782 and one or more groovesformed in the guide members 780 configured to engage the one or moredetents when the needle removal device 752 is in the grasping position.In other embodiments, the locking features may be omitted.

As shown in FIG. 7A and FIG. 7B, the needle removal device 752 mayinclude one or more needle receptacles 762 configured to receive theneedles 708. The one or more needle receptacles 762 may be defined atleast partially between the sliding members 782 and the base member 756.The one or more needle receptacles 762 may be configured and positionedto generally correspond to needle lumens 736 at the proximal end of theguide body 702. Such a configuration may allow the needles 708 to bereceived within the one or more needle receptacles 762 when the needles708 exit the needle lumens 736. Such a configuration may allow a user toexert a force in the proximal direction on the needles 708 to overcomean initial resistance to removal of the needles 708 from the guide body702. For example, in the grasping position, the needle removal device752 may allow a user to exert a force in the proximal direction of aboutone quarter (0.25) pound-force to seventy (70) pound-force; about one(1) pound-force to sixty (60) pound-force; or about five (5) pound-forceto forty (40) pound-force on the needles 708. In other embodiments, theneedle removal device 752 may allow a user to exert larger or smallerforces on the needles 708. In yet other embodiments, the one or moreneedle receptacles 762 may include one or more gripping featuresconfigured to enhance the grip of the needle removal device 752 on theneedles 708. For example, the one or more needle receptacles 762 mayinclude textured surfaces, contoured surfaces, adhesives, magnets, orthe like.

FIGS. 8A through 8C illustrate exemplary steps in a method for removingthe needles 708 from the suturing system 70 with the needle removaldevice 752. While the method is illustrated using the suturing system 70and the needle removal device 752, it will be appreciated that thedescribed method may utilize any other needle removal device and/orsuturing system disclosed herein. Only certain exemplary steps ofremoving the needles 708 from the suturing system 70 are shown anddescribed, however, it will be appreciated that the method may followdelivery of needles and suture lengths through body tissue or a vesselwall by the suturing system 70. For example, the method may include anyof the steps previously described and/or illustrated in relation toFIGS. 2A through 2D.

Referring now to FIG. 8A, to deploy the needles 708, the handle 718(shown in FIG. 7A) may be drawn proximally relative to the guide body702 to proximally move the needle deployment shaft 712. As shown, theneedle deployment shaft 712 may draw the needles 708 proximally throughthe needle lumens 736 of the guide body 702 until the needles 708 exitthe guide body 702 within the hub 748. As the needles 708 exit the guidebody 702, the needles 708 may be received within the needle receptacles762 while the needle removal device 752 is in the receiving position asshown.

Referring now to FIG. 8B, the sliding members 782 may be squeezed orpushed together toward the base member 756 to slidably move the needleremoval device 752 into the grasping position. The sliding members 782may be squeezed or pushed together with a user's fingers, a medicalinstrument, or any other suitable means. In the grasping position, theneedles 708 may be grasped by the needle removal device 752 between thesliding members 782 and the base member 756 in the needle receptacles762.

Referring now to FIG. 8C, with the needle removal device 752 in thegrasping position, the needle removal device 752 may be moved proximallyrelative to the guide body 702. The needle removal device 752 may beconfigured to overcome an initial resistance to proximal movement of theneedles 708 from the guide body 702. Proximal movement of the needleremoval device 752, in turn, may continue to remove the needles 708 fromthe guide body 702. Once the needles 708 are removed from the guide body702, suture lengths (not shown) attached to the needles 708 may be cutand the needles 708 may be disposed of. Such a configuration of theneedle removal device 752 may allow a user to safely and securely removethe needles 708 from the suturing system 70.

Another embodiment of a needle removal device will now be described inrelation to FIGS. 9A through 10C. A suturing system 90 may be similar inmany respects to the suturing systems 10, 30, 50 and 70 previouslydescribed above in FIGS. 1A-8C. To the extent features or components ofthis configuration function in a manner similar to that as describedabove, such disclosure is hereby incorporated into the followingadditional configuration. Similar to suturing systems 30, 50, and 70,for ease of reference, only the proximal portion of the suturing system90 is shown and described. The distal components may be manipulated bythe proximal components in a similar manner as described with referenceto FIGS. 1A through 8C.

FIG. 9A is a partial side perspective view of the suturing system 90.The suturing system 90 may include a guide body 902, a needle guide (notshown) secured to a distal end of the guide body 902, and a flexibletube (not shown) secured to a distal end of the needle guide. A sheath920 may be rotatably received over the guide body 902. A plurality ofneedles 908 (shown in FIG. 10A) may be mounted with their distal ends ina support holster (not shown) and attached to a moveable needledeployment shaft 912 (shown in FIG. 10A). A handle assembly 914 may beattached to a proximal end of the guide body 902. The handle assembly914 may include a pair of interlock wings 916, a needle removal device952, and a handle 918. The handle 918 may be attached to a proximal endof the needle deployment shaft 912 and may be pulled proximally in orderto draw the needles 908 from the flexible tube, through the needle guideand into the guide body 902 until the needles 908 emerge from the guidebody 902 within a hub 948. Once the needles 908 emerge within the hub948, the needles 908 may be received with the needle removal device 952.

FIG. 9B is a partial cutaway isometric view of the needle removal device952 removed from the suturing system 90. As shown, the needle removaldevice 952 may include a base member 956, a knob 982, and an outercasing 984. The base member 956 may have a generally cylindricalgeometric shape and include a shaft 986 attached to an upper surface ofthe base member 956. A central aperture 954 may extend through the basemember 956 and the shaft 986. The central aperture 954 may be configuredto allow a stem 938 (shown in FIG. 10A) of the handle assembly 914 topass through the base member 956 and the shaft 986 such that the needleremoval device 952 may be selectively positioned between the guide body902 and the handle 918. The central aperture 954 may also be configuredto receive the needle deployment shaft 912 such that the needledeployment shaft may be selectively drawn through the base member 956and the shaft 986. Such a configuration may allow the needle deploymentshaft 912 and the needle removal device 952 to move axially relative toone another. The shaft 986 may include an outer threaded portion havinga male or female thread.

As shown, a plurality of needle receptacles 962 may be formed in thebase member 956 and extend therethrough. One or more of the needlereceptacles 962 may have a generally cylindrical geometric shape,generally conical geometric shape, generally oval geometric shape, orany other suitable geometric shape. The needle receptacles 962 may beconfigured and positioned in the base member 956 to generally correspondto needle lumens 936 (shown in FIG. 9A) extending through the guide body902. Such a configuration allows the needles 908 to be selectivelyreceived within the needle receptacles 962 when the needles 908 exit theneedle lumens 936 of the guide body 902. While four needle receptacles962 are shown formed in the base member 956, three, five, two, or anyother suitable number of needle receptacles 962 may be formed in thebase member 956 in any suitable configuration.

The knob 982 may have a generally cylindrical geometric shape andinclude an upper surface, a lower surface, and a side surface. The knob982 may include ridges formed in the side surface configured to providea user an improved grip on the knob 982. In other embodiments, the sidesurface of the knob 982 may include other features configured to improvethe user's grip on the knob such as indentations for a user's fingers ortools or other suitable features.

The knob 982 may include an aperture 980. The aperture 980 may includean inner threaded portion with female or male thread configured torotatably engage the outer threaded portion of the shaft 986. The basemember 956 may move toward the knob 982 when the shaft 986 is threadedinto the aperture of the knob 982 and the base member 956 may move awayfrom the knob 982 when the shaft 986 is unthreaded from the aperture 980of the knob 982.

The outer casing 984 may be attached to the bottom surface of the knob982 and may be configured to at least partially receive the base member956. The outer casing 984 may be rotatably attached to the knob 982 orthe outer casing 984 may be integral and/or affixed to the knob 982. Asshown, the outer casing 984 may include an inner surface having a firstdiameter in a distal portion that tapers proximally to a second diameterin a proximal portion.

At least a portion of the base member 956 may be formed of one or moresubstantially resilient materials such as polymers, polymericcomposites, metals, combinations thereof, or the like. Configuring thebase member 956 in this manner may allow the needle removal device 952to move between a receiving position, wherein at least a portion of eachneedle 908 can pass through the needle receptacles 962, and a graspingposition wherein the base member 956 may grasp or pinch the needles 908within the needle receptacles 962. For example, in the receivingposition the base member 956 may be positioned near the distal portionof the outer casing 984. Once needles 908 are received within the needlereceptacles 962, the shaft 986 may be threaded through the knob 982 tomove the knob 982 and the base member 956 closer to one another. As thebase member 956 and the knob 982 move closer together, the tapered innersurface of the outer casing 984 may exert increasing external pressureon the base member 956 as the diameter of the inner surface of the outercasing 984 decreases. The external pressure on the base member 956 mayin turn cause one or more of the needle receptacles 962 to deform orelongate such that a compression fit is formed between the needles 908and the needle receptacles 962. The needle removal device 952 may beconfigured to allow a user to exert a force in the proximal direction onthe needles 908 to overcome an initial resistance to removal of theneedles 908 from the guide body 902. For example, in the graspingposition, the needle removal device 952 may allow a user to exert aforce in the proximal direction of about one quarter (0.25) pound-forceto seventy (70) pound-force; about one (1) pound-force to sixty (60)pound-force; or about five (5) pound-force to forty (40) pound-force onthe needles 908 to overcome an initial resistance to proximal movementof the needles 908 from the guide body 902. In other embodiments, theneedle removal device 952 may allow a user to exert larger or smallerforces on the needles 908.

FIGS. 10A through 10C illustrate exemplary steps in a method forremoving the needles 908 from the suturing system 90 with the needleremoval element 952. While the method is illustrated using the suturingsystem 90 and the needle removal device 952, it will be appreciated thatthe described method may utilize any other needle removal device and/orsuturing system disclosed herein. Only certain exemplary steps ofremoving the needles 908 from the suturing system 90 are shown anddescribed, however, it will be appreciated that the method may followdelivery of needles and suture lengths through body tissue or a vesselwall by the suturing system 90. For example, the method may include anyof the steps previously described and/or illustrated in relation toFIGS. 2A through 2D.

Referring now to FIG. 10A, to deploy the needles 908, the handle 918(shown in FIG. 9A) may be drawn proximally relative to the guide body902 to proximally move the needle deployment shaft 912. As shown, theneedle deployment shaft 912 may draw the needles 908 proximally throughthe needle lumens 936 of the guide body 902 until the needles 908 exitthe guide body 902 within the hub 948. As the needles 908 exit the guidebody 902, the needles 908 may be received within the needle receptacles962 with the needle removal device 952 in the receiving position asshown. As shown, tips of the needles 908 may be received and positionedwithin the needle removal device 952 such that risk of injury to theuser or a patient is reduced.

Referring now to FIG. 10B, the knob 982 may be rotated relative to theshaft such that the base member 956 and the knob 982 move closertogether. As the base member 956 and the knob 982 move closer together,the needle removal device 952 may move into the grasping position.Specifically, as the base member 956 and the knob 982 move closertogether, the inner surface of the outer casing 984 may exert anincreasing external pressure on the base member 956 such that the needlereceptacles 962 deform to create a compression fit between the needles908 and the needle receptacles 962. If a user desires to increase thestrength of the compression fit, the user may continue to move the knob982 and the base member 956 closer together such that the externalpressure on the base member 956 increases. Accordingly, a user maycontrol the grasping strength of the needle removal device 952 on theneedles 908 with relative rotation between the knob 982 and the basemember 956.

Referring now to FIG. 10C, with the needle removal device 952 in thegrasping position, the needle removal device 952 may be moved proximallyrelative to the guide body 902. Proximal movement of the needle removaldevice 952, in turn, may continue to remove the needles 908 from theguide body 902. The compression fit between the needles 908 and theneedle receptacles 962 may be configured to overcome an initialresistance to proximal movement of the needles 908 from the guide body902. Once the needles 908 are removed from the guide body 902, suturelengths (not shown) attached to the needles 908 may be cut and theneedles 908 may be disposed of. Such a configuration of the needleremoval device 752 may allow a user to safely and securely remove theneedles 708 from the suturing system 70.

In yet other embodiments, needle removal devices may be configured tosecure needles for removal from suturing systems by at least partiallydeforming the needles as described in U.S. Patent Application, entitled“Needle Harvesting Devices, Systems and Methods,” Ser. No. 13/610,602,filed on the same day, the disclosure of which is incorporated herein inits entirety.

Embodiments of the suturing device, needle removal device and the likemay include a material made from any of a variety of known suitablebiocompatible materials, such as a biocompatible shape memory material(SMM). For example, the SMM may be shaped in a manner that allows forthe needle removal device to automatically move from the receivingposition to the grasping position when needles are received within theneedle receptacles. SMMs have a shape memory effect in which they may bemade to remember a particular shape. Once a shape has been remembered,the SMM may be bent out of shape or deformed and then returned to itsoriginal shape by unloading from strain or heating. Typically, SMMs maybe shape memory alloys (SMA) comprised of metal alloys, or shape memoryplastics (SMP) comprised of polymers. The materials may also be referredto as being superelastic.

Usually, an SMA may have an initial shape that may then be configuredinto a memory shape by heating the SMA and conforming the SMA into thedesired memory shape. After the SMA is cooled, the desired memory shapemay be retained. This allows for the SMA to be bent, straightened,twisted, compacted, and placed into various contortions by theapplication of requisite forces; however, after the forces are released,the SMA may be capable of returning to the memory shape. The main typesof SMAs are as follows: copper-zinc-aluminum; copper-aluminum-nickel;nickel-titanium (NiTi) alloys known as nitinol; nickel-titaniumplatinum; nickel-titanium palladium; and cobalt-chromium-nickel alloysor cobalt-chromium-nickel-molybdenum alloys known as elgiloy alloys. Thetemperatures at which the SMA changes its crystallographic structure arecharacteristic of the alloy, and may be tuned by varying the elementalratios or by the conditions of manufacture.

For example, the primary material of needle removal device may be of aNiTi alloy that forms superelastic nitinol. Also, additional materialsmay be added to the nitinol depending on the desired characteristic. Thealloy may be utilized having linear elastic properties or non-linearelastic properties.

An SMP is a shape-shifting plastic that may be fashioned into the needlereceptacles of the base member in accordance with the presentdisclosure. Also, it may be beneficial to include at least one layer ofan SMA and at least one layer of an SMP to form a multilayered body;however, any appropriate combination of materials may be used to form amultilayered device. When an SMP encounters a temperature above thelowest melting point of the individual polymers, the blend makes atransition to a rubbery state. The elastic modulus may change more thantwo orders of magnitude across the transition temperature (Ttr). Assuch, an SMP may be formed into a desired shape of an endoprosthesis byheating it above the Ttr, fixing the SMP into the new shape, and coolingthe material below Ttr. The SMP may then be arranged into a temporaryshape by force and then resume the memory shape once the force has beenreleased. Examples of SMPs include, but are not limited to,biodegradable polymers, such as oligo(ε-caprolactone)diol,oligo(p-dioxanone)diol, and non-biodegradable polymers such as,polynorborene, polyisoprene, styrene butadiene, polyurethane-basedmaterials, vinyl acetate-polyester-based compounds, and others yet to bedetermined. As such, any SMP may be used in accordance with the presentdisclosure.

The needle receptacles and the like may have at least one layer made ofan SMM or suitable superelastic material and other suitable layers thatcan allow the needle receptacles to automatically grasp onto theneedles.

Also, the needle removal devices, the needle receptacles or otheraspects or components of the system may be comprised of a variety ofknown suitable deformable materials, including stainless steel, silver,platinum, tantalum, palladium, nickel, titanium, nitinol, nitinol havingtertiary materials (U.S. 2005/0038500, which is incorporated herein byreference, in its entirety), niobium-tantalum alloy optionally dopedwith a tertiary material (U.S. 2004/0158309, 2007/0276488, and2008/0312740, which are each incorporated herein by reference, in theirentireties) cobalt-chromium alloys, or other known biocompatiblematerials. Such biocompatible materials may include a suitablebiocompatible polymer in addition to or in place of a suitable metal.The polymeric needle removal device may include biodegradable orbioabsorbable materials.

In one embodiment, the needle removal device and/or needle receptaclesmay be made from a superelastic alloy such as nickel-titanium ornitinol, and includes a ternary element selected from the group ofchemical elements consisting of iridium, platinum, gold, rhenium,tungsten, palladium, rhodium, tantalum, silver, ruthenium, or hafnium.The added ternary element improves the radiopacity of the nitinol knotreplacement element. The nitinol needle removal device has improvedradiopacity yet retains its superelastic and shape memory behavior andfurther maintains a thin body thickness for high flexibility.

In one embodiment, the needle removal device and/or the needlereceptacles may be made at least in part of a high strength, low modulusmetal alloy comprising Niobium, Tantalum, and at least one elementselected from the group consisting of Zirconium, Tungsten, andMolybdenum.

In further embodiments, the needle removal device and/or the needlereceptacles may be made from or be coated with a biocompatible polymer.Examples of such biocompatible polymeric materials may includehydrophilic polymer, hydrophobic polymer, biodegradable polymers,bioabsorbable polymers, and monomers thereof. Examples of such polymersmay include nylons, poly(alpha-hydroxy esters), polylactic acids,polylactides, poly-L-lactide, poly-DL-lactide,poly-L-lactide-co-DL-lactide, polyglycolic acids, polyglycolide,polylactic-co-glycolic acids, polyglycolide-co-lactide,polyglycolide-co-DL-lactide, polyglycolide-co-L-lactide, polyanhydrides,polyanhydride-co-imides, polyesters, polyorthoesters, polycaprolactones,polyesters, polyanydrides, polyphosphazenes, polyester amides, polyesterurethanes, polycarbonates, polytrimethylene carbonates,polyglycolide-co-trimethylene carbonates, poly(PB A-carbonates),polyfumarates, polypropylene fumarate, poly(p-dioxanone),polyhydroxyalkanoates, polyamino acids, poly-L-tyrosines,poly(beta-hydroxybutyrate), polyhydroxybutyrate-hydroxyvaleric acids,polyethylenes, polypropylenes, polyaliphatics, polyvinylalcohols,polyvinylacetates, hydrophobic/hydrophilic copolymers, alkylvinylalcoholcopolymers, ethylenevinylalcohol copolymers (EVAL),propylenevinylalcohol copolymers, polyvinylpyrrolidone (PVP),combinations thereof, polymers having monomers thereof, or the like.

The coatings can also be provided on the system or components thereof tofacilitate the loading or delivery of beneficial agents or drugs, suchas therapeutic agents, pharmaceuticals and radiation therapies.

The invention is susceptible to various modifications and alternativemeans, and specific examples thereof have been shown by way of examplein the drawings and are herein described in detail. It should beunderstood, however, that the invention is not to be limited to theparticular systems or methods disclosed, but to the contrary; theinvention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the claims.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

What is claimed is:
 1. A medical device comprising: an elongate memberextending from a proximal end toward a distal end, the elongate memberhaving a lumen with a longitudinal axis; a first proximal assemblytowards the proximal end of the elongate member; a second proximalassembly cooperating with the first proximal assembly, the secondproximal assembly comprising: a base portion comprising a groove havinga gap and an opening, the base portion being configured to cooperatewith a portion of the first proximal assembly; and two wings beingopposite sides of the base portion, the two wings being configured tomove in relation to the longitudinal axis of the elongate member tochange the gap of the groove, the two wings extending from a proximalend of the first proximal assembly.
 2. The medical device of claim 1,wherein each wing has an elongate slot having a closed first end at alocation between the base portion and a peripheral end of the wing. 3.The medical device of claim 1, wherein each of the two wings include atextured surface.
 4. A method of forming a medical device comprising:providing a first medical device portion comprising: an elongate member;a stem disposed towards a proximal end of the first medical deviceportion and proximal the elongate member, the stem comprising aprotruding portion extending from one side of a stem portion; and alumen extending through the elongate member and the stem; andpositioning a second medical device portion over the stem so that thesecond medical device portion at least partially surrounds a portion ofthe first medical device portion, the second medical device portioncomprising: a base portion with a groove having a gap; and two wingsextending from the base portion, the wings being opposite each other onopposite sides of the base portion, the two wings being configured tomove in relation to the longitudinal axis to change the gap of thegroove.
 5. The method of claim 4, wherein positioning the second medicaldevice portion over the stem, further comprises mounting the secondmedical device portion to the stem of the first medical device portion.6. The method of claim 4, wherein the base portion is formed of apolymer.
 7. The method of claim 4, wherein each wing of the two wingscomprises a first portion angularly orientated in relation to a secondportion, the second portion extending to and forming the peripheral end.8. The method of claim 7, wherein the elongate slot of each wingextending over at least a portion of each of the first portion and thesecond portion.
 9. The method of claim 4, wherein each of the two wingsinclude a textured surface.
 10. The method of claim 4, wherein each ofthe two wings include ridges.
 11. The method of claim 4, wherein thebase portion further comprises a second groove disposed from the firstgroove by an opening.
 12. The method of claim 4, wherein the two wingsare integral with the base portion.
 13. The method of claim 4, whereinthe stem comprises a slot.